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NCT01572493 · ClinicalTrials.gov registry record · Phase 1
Continuous Infusion of rhIL-15 for Adults With Advanced Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT01572493: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01572493 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 38 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01572493, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
Background: \- People with cancer can have a weak immune system as a result of the cancer itself, or from prior treatments. Still, treatments that stimulate the immune system have been shown to be effective against a number of different cancers. Recombinant human interleukin-15 (rhIL-15) is a drug that is designed to boost the immune system. Researchers are interested in seeing if rhIL-15 can strengthen the immune system's response against cancer. The drug will be given through a vein without a break for 10 days (240 hours). Objectives: * To see rhIL-15 given as a continuous infusion over 10 days can be used to treat advanced cancer * Identify the side effects associated with this treatment. Eligibility: \- Individuals at least 18 years of age with advanced cancer for which there are no effective treatments. Design: * Participants screening procedures will include a physical exam and medical history, laboratory (blood) tests and x-rays (Imaging studies) to determine suitability for the protocol. * Appropriate participants with easily accessible tumor deposits may also be asked to have one pretreatment and one post (cycle 1) treatment tumor biopsy. * Eligible participants will be admitted to the hospital for the rhIL-15 treatment and will spend about 12 days in the hospital. * Participants will receive one 10 day infusion each cycle (about every 42 days) for as long as there are no serious side effects and the disease does not progress. * Participants will continue treatment as long as imaging studies show that the tumor continues to shrink or for two additional cycles after it has disappeared from the x-rays to make that the cancer is completely gone. * Participants who stop treatment for side effects or because their tumor did not shrink or stopped responding to the treatment will continue to have follow-up visits to monitor the outcome of the rhIL-15 treatment until there is evidence their cancer has progress or they begin another treatment.
Interventions
- BIOLOGICAL rh IL-15 (10 DAYS)
- BIOLOGICAL rh IL-15 (5 DAYS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2012-04-04 |
| Est. Completion | 2019-07-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01572493
The ClinicalTrials.gov registry entry for NCT01572493 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which rh IL-15 (10 DAYS) is the first listed.
NCT01572493 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01572493 about?
NCT01572493 is a clinical study titled "Continuous Infusion of rhIL-15 for Adults With Advanced Cancer". Background: \- People with cancer can have a weak immune system as a result of the cancer itself, or from prior treatments. Still, treatments that stimulate the immune system have been shown to be effective against a number of different cancers. Recombinant human interleukin-15 (rhIL-15) is a drug ...
What is the current status of trial NCT01572493?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2012-04-04. Estimated completion is 2019-07-02.
What interventions are being tested in trial NCT01572493?
The interventions under investigation include: rh IL-15 (10 DAYS) (BIOLOGICAL), rh IL-15 (5 DAYS) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01572493?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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